MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Fluid Discharge (2686)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of the possible infection and fluid discharge issue.Reportedly, the patient had water sac under the arm, and the icd had been leaking.The physician informed that the patient may have a bacterial infection.The patient added that the water sac had been there for several months.The boston scientific technical services (ts) informed that the icd was not on any advisories and does not leak.No additional adverse patient effects were reported.The icd remains implanted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was part of the possible infection and fluid discharge issue.Reportedly, the patient had water sac under the arm, and the icd had been leaking.The physician informed that the patient may have a bacterial infection.The patient added that the water sac had been there for several months.The boston scientific technical services (ts) informed that the icd was not on any advisories and does not leak.No additional adverse patient effects were reported.The icd remains implanted.Additional information indicated that the icd was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental report is being filed to correct the d6b: explant date; g2: report source; h2: follow-up type; h3: device eval by manufacturer; h6: patient codes; and h11: additional mfr narrative.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23669049
• Report Number: 2124215-2025-87398
• Device Sequence Number: 21302689
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)190717
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/17/2019
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 214510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 07/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female